PEG-IFN lambda: Additional Phase II data

Data from 118 treatment-naïve patients with chronic HCV genotype 2 or 3 infection in the Phase IIb portion of the international Phase II EMERGE trial showed that 65.5%, 75.9% and 60% of patients achieved an SVR defined as undetectable HCV RNA levels 24 weeks after completing 24 weeks of treatment with once-weekly 120, 180 and 240 µg subcutaneous PEG-interferon lambda, respectively, plus ribavirin vs. 53.3% of patients receiving peginterferon alfa-2a plus ribavirin. Specifically, in treatment-naïve patients with chronic HCV genotype 2 infection (n=60), SVR24 rates were 58.3%, 70.6% and 62.5% for low-, mid- and high-dose PEG-interferon lambda plus ribavirin, respectively, vs. 66.7% for peginterferon alfa-2a and ribavirin. In treatment-naïve patients with chronic HCV genotype 3 infection (n=58), SVR24 rates were 70.6%, 83.3% and 57.1% for low-, mid- and high-dose PEG-interferon lambda plus ribavirin, respectively, vs. 40% for peginterferon alfa-2a and ribavirin.

Furthermore, relapse rates defined as HCV RNA levels >=25 IU/mL during post-treatment follow-up were 25%, 18.5% and 5.3% for low-, mid- and high-dose PEG-interferon lambda plus ribavirin, respectively, vs. 22.7% for peginterferon alfa-2a plus ribavirin. Patients with HCV genotype 1 or 4 infection received 48 weeks of treatment with peginterferon alfa-2a or once-weekly 120, 180 or 240 µg PEG-interferon lambda plus ribavirin, while patients with HCV genotype 2 or 3 infection received 24 weeks of treatment. Data were presented at the European Association for the Study of the Liver meeting in Barcelona. Bristol-Myers said it selected the 180 µg dose of PEG-interferon lambda for evaluation in Phase III trials, but did not provide a timeline for when the trials will start. ...